Mayo Clinic enrolls first patient for ExThera Medical’s PURIFY-RCT II trial

MARTINEZ, Calif. – ExThera Medical Corporation’s PURIFY-RCT II trial to evaluate the efficacy of pathogen removal from severely ill patients suffering from pathogen shock is moving forward with the first patient enrollment at Mayo Clinic.  This comes after ExThera Medical completed the first phase of the prospective interventional multicenter PURIFY-RCT trial.

“Enrolling the first patient in this phase of the trial is a crucial milestone toward commercial availability and growth in this therapy space,” said Erin Borger, CEO of ExThera Medical.

The PURIFY-RCT trial is sponsored by the Department of Defense in collaboration with the Henry M. Jackson Foundation and the Uniformed Services University of Health Sciences to evaluate the safety and efficacy of the Seraph^® 100 Microbind^® Affinity Blood Filter. The clinical trial will be conducted in centers across the United States, targeting improvements in both clinical outcome and health economic endpoints.

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About ExThera Medical Corporation

ExThera Medical Corporation develops extracorporeal blood filtration devices, including the Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100) for removing a broad range of pathogens from the bloodstream of patients. Seraph 100 can be used in hospitals, clinics, on battlefields and in other austere environments. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from the EU, the company is well positioned to serve healthcare professionals and patients alike.

The Seraph 100 device has neither been cleared nor approved by the U.S. Food and Drug Administration (FDA) for any indication. The Seraph 100 has been authorized by FDA under an Emergency Use Authorization (EUA) to treat patients with COVID-19 infection. The Seraph 100 is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph 100 device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

For more information, visit the company’s website at https://extheramedical.com/.

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